alexa Statistical methods to analyze adverse events data of randomized clinical trials.


Journal of Biometrics & Biostatistics

Author(s): Siddiqui O

Abstract Share this page

Abstract The adverse events data of randomized clinical trials are often analyzed based on either crude incidence rates or exposure-adjusted incidence rates. These rates do not adequately account for an individual patient's profile of adverse events over the study period when an individual may remain in the trial after experiencing one or more events (i.e., occurrence of multiple events of the same kind or different kinds). Moreover, the required statistical assumptions (e.g., constant hazard rate over time) for valid estimates of incidence rates are not likely to be met in practice by adverse events data of clinical trials. A nonparametric approach called the mean cumulative function (MCF) provides a valid statistical inference on recurrent adverse event profiles of drugs in randomized clinical trials. The estimate involves no assumptions about the form of MCF. To demonstrate the applicability and utility of the MCF approach in clinical trial datasets, an adverse event dataset obtained from a clinical trial is analyzed in this article. As compared to the crude or exposure-adjusted incidence rates of adverse events, the MCF estimates facilitate more understanding of safety profiles of a drug in a randomized clinical trial. This article was published in J Biopharm Stat and referenced in Journal of Biometrics & Biostatistics

Relevant Expert PPTs

Relevant Speaker PPTs

Recommended Conferences

Relevant Topics

Peer Reviewed Journals
Make the best use of Scientific Research and information from our 700 + peer reviewed, Open Access Journals
International Conferences 2017-18
Meet Inspiring Speakers and Experts at our 3000+ Global Annual Meetings

Contact Us

Agri, Food, Aqua and Veterinary Science Journals

Dr. Krish

1-702-714-7001 Extn: 9040

Clinical and Biochemistry Journals

Datta A

1-702-714-7001Extn: 9037

Business & Management Journals


1-702-714-7001Extn: 9042

Chemical Engineering and Chemistry Journals

Gabriel Shaw

1-702-714-7001 Extn: 9040

Earth & Environmental Sciences

Katie Wilson

1-702-714-7001Extn: 9042

Engineering Journals

James Franklin

1-702-714-7001Extn: 9042

General Science and Health care Journals

Andrea Jason

1-702-714-7001Extn: 9043

Genetics and Molecular Biology Journals

Anna Melissa

1-702-714-7001 Extn: 9006

Immunology & Microbiology Journals

David Gorantl

1-702-714-7001Extn: 9014

Informatics Journals

Stephanie Skinner

1-702-714-7001Extn: 9039

Material Sciences Journals

Rachle Green

1-702-714-7001Extn: 9039

Mathematics and Physics Journals

Jim Willison

1-702-714-7001 Extn: 9042

Medical Journals

Nimmi Anna

1-702-714-7001 Extn: 9038

Neuroscience & Psychology Journals

Nathan T

1-702-714-7001Extn: 9041

Pharmaceutical Sciences Journals

John Behannon

1-702-714-7001Extn: 9007

Social & Political Science Journals

Steve Harry

1-702-714-7001 Extn: 9042

© 2008-2017 OMICS International - Open Access Publisher. Best viewed in Mozilla Firefox | Google Chrome | Above IE 7.0 version